WO2011077286A1 - Ensemble cathéter à introduction entérale incorporant un indicateur - Google Patents

Ensemble cathéter à introduction entérale incorporant un indicateur Download PDF

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Publication number
WO2011077286A1
WO2011077286A1 PCT/IB2010/055341 IB2010055341W WO2011077286A1 WO 2011077286 A1 WO2011077286 A1 WO 2011077286A1 IB 2010055341 W IB2010055341 W IB 2010055341W WO 2011077286 A1 WO2011077286 A1 WO 2011077286A1
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WO
WIPO (PCT)
Prior art keywords
balloon
pressure
volume
catheter
indicator
Prior art date
Application number
PCT/IB2010/055341
Other languages
English (en)
Inventor
Adrienne A. Hershey
Donald J. Mcmichael
John A. Rotella
Original Assignee
Kimberly-Clark Worldwide, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kimberly-Clark Worldwide, Inc. filed Critical Kimberly-Clark Worldwide, Inc.
Priority to EP10798192.0A priority Critical patent/EP2515825B1/fr
Priority to MX2012007430A priority patent/MX338783B/es
Priority to JP2012545484A priority patent/JP5809639B2/ja
Priority to CN201080059225.4A priority patent/CN102665646B/zh
Priority to BR112012015019A priority patent/BR112012015019A2/pt
Priority to CA2781494A priority patent/CA2781494C/fr
Priority to RU2012131060/15A priority patent/RU2561047C2/ru
Priority to KR1020127016305A priority patent/KR101743015B1/ko
Priority to ES10798192.0T priority patent/ES2589779T3/es
Priority to AU2010334500A priority patent/AU2010334500B2/en
Publication of WO2011077286A1 publication Critical patent/WO2011077286A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
    • A61J15/0042—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0046—Expandable retainers inside body lumens of the enteral tract, e.g. fixing by radially contacting a lumen wall
    • A61J15/0049—Inflatable Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0053—Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin
    • A61J15/0065—Fixing means and tube being one part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/008—Sensor means, e.g. for sensing reflux, acidity or pressure
    • A61J15/0088—Sensor means, e.g. for sensing reflux, acidity or pressure for sensing parameters related to the device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0092—Valves on feeding tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/044—External cuff pressure control or supply, e.g. synchronisation with respiration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10185—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10187—Indicators for the level of inflation or deflation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10187—Indicators for the level of inflation or deflation
    • A61M25/10188—Inflation or deflation data displays
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L7/00—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements
    • G01L7/02—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges
    • G01L7/06—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges of the bellows type
    • G01L7/063—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges of the bellows type with mechanical transmitting or indicating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/70—Device provided with specific sensor or indicating means
    • A61J2200/76—Device provided with specific sensor or indicating means for fluid level
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • A61M2039/085—Tubes; Storage means specially adapted therefor external enteral feeding tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1053—Stomach

Definitions

  • the present invention relates to improved gastrostomy tubes or enteral feeding catheters.
  • Balloons can be used in place of these conventional devices with Malecot tips or similar expanding tips.
  • a balloon typically made of a "soft” or elastomeric medical grade silicone, is attached to the end of the catheter and is deflated for insertion through the stoma and then inflated to hold the enteral feeding assembly in position. While these balloons have many advantages, balloons may eventually leak and deflate.
  • "soft" or elastomeric medical grade silicone has a tendency to "creep" or stress relax over time which can change the dimensions of the balloon.
  • endotracheal tubes and tracheostomy tubes utilize inflatable balloons to create a seal that prevents the passage of mucus into the lungs.
  • Pilot balloons, pressure gauges, and inflation indicators are used to provide a continuous reading of the pressure in the balloon in these devices. That is, these devices provide an output that conveys continuous or uninterrupted information showing pressure increases and decreases in the balloon.
  • pressure indicators incorporating bellows or diaphragms are known and electronic pressure indicators are known.
  • a simple bellows pressure indicator for showing continuous reading of fluid pressure is described in U.S. Patent No. 3,780,693 for "Visible Fluid Pressure Indicator” to Parr.
  • U.S. Patent No. 7,383,736 "Device and Method for Pressure Indication” issued to Esnouf, describes a bellows device for use with a laryngeal mask balloon or other airway management equipment incorporating balloons.
  • the device of Esnouf incorporates a bellows that is displaced by a differential pressure between the outside of the bellows and the inside of the bellows to provide a continuous reading of the increases and decreases in the pressure of fluid in the balloon.
  • the device of Igarashi et al. is connected to the balloon through an inflation tube and has an inflation valve at the other end that is connected to a syringe.
  • the device uses a bellows and/or spring indicator provide a continuous reading and display of the increase and decrease in the pressure of fluid in the balloon through movement of the bellows against a numerical scale printed on the housing.
  • U.S. Patent No. 5,218,970 for "Tracheal Tube Cuff Pressure Monitor” issued to Turnbull et al. describes a continuous pressure monitor for a tracheal tube incorporating an electronic pressure sensor such as a silicon strain gauge pressure sensor, a processor that performs various calibration, scaling and calculation operations on the signal from the sensor and provides an output to a numeric display conveying a continuous reading of the increases and decreases in the pressure of fluid in the balloon.
  • These indicators are adapted for airway devices where careful and constant monitoring of balloon pressure is important.
  • these pilot balloons, bellows and diaphragms indicators and electronic sensors are designed to convey a continuous reading of the increases and decreases in the pressure of fluid in the balloon.
  • pilot balloons and similar bellows or diaphragm indicators are relatively large and typically require skill and experience to accurately interpret the output of these conventional devices as they provide a continuous reading of pressure.
  • electronic pressure sensors are accurate and are generally easy to read, they are relatively large and expensive. Scaling these types of devices down to a sufficiently small size so they can be used with a low-profile PEG tube only highlights the problems associated with the size, calibration, accuracy, and reading or interpreting the output of these devices.
  • U.S. Patent No. 6,878,130 for "External Inflation Indicator for a Low Profile Gastrostomy Tube" issued to Fournie et al. describes an external inflationary indicator similar to a pilot balloon integrated into the base of a gastrostomy device having a retainer balloon.
  • the device of Fournie et al. provides a continuous tactile reading of the inflationary state of the retainer balloon.
  • the Fournie et al. device utilizes two generally bubble-like portions that assume a generally convex shape when the retainer balloon is inflated and a generally concave shape when the balloon is deflated. The changing shape of these generally bubble-like portions provides a continuous tactile indication or reading of the inflationary state of the balloon.
  • the external inflationary indicator provides continuous visual indication of the inflationary state of the retainer balloon through the use of a separating bar dividing these two generally bubble-like portions of the indicator.
  • the separating bar visually separates as the balloon becomes fully inflated to indicate the inflationary state.
  • Such continuous indication of the inflationary state is important for conventional PEG tube retainer balloons made of elastic materials such as "soft" or elastomeric medical grade silicone because these elastic materials must stretched to increase the balloon volume. Relatively large changes in pressure are needed to stretch such elastic materials from an un-stretched state to expand the balloon.
  • the relationship between the amount of pressure needed to stretch such elastic materials to expand the balloon and the volume of the balloon is nonlinear. That is, and the correlation between the pressure of the fluid inside the balloon and the volume of the balloon is not simple which leads to the use of continuous indicators designs such as those described by Fournie et al., if any indicator is used at all.
  • FIG. 1 A is an illustration of a conventional PEG tube device 10 having a base 12 and retainer balloon 13 made of conventional "soft" or elastomeric medical grade silicone in an un-stretched state (i.e., un-inflated condition).
  • a pilot-balloon type indicator 15 as generally described by Fournie et al. is located in the base 12 of the conventional PEG tube device 10.
  • FIG. 1 B is an illustration of a conventional PEG tube device 10 having a base 12 and retainer balloon 13 made of conventional "soft" or elastomeric medical grade silicone which has been stretched by inflation to an inflated volume.
  • a pilot-balloon type indicator 15 as generally described by Fournie et al. is located in the base 12 of the conventional PEG tube device 10.
  • FIG. 1 A is an illustration of a conventional PEG tube device 10 having a base 12 and retainer balloon 13 made of conventional "soft" or elastomeric medical grade silicone in an un-stretched state (i.e., un-inflated condition
  • FIG. 1 C is an illustration showing an exemplary relationship between the pressure of a fluid inside such an elastic retainer balloon and the balloon volume during the stretching the conventional "soft" or elastomeric medical grade silicone forming the balloon by increasing the pressure of a fluid inside the balloon.
  • the illustration is a pressure versus volume plot for a Kimberly-Clark® Mic-Key® 12 french low profile gastrostomy feeding tube with a silicone balloon.
  • stretching such elastic balloons from negligible volume (i.e., a deflated condition) at negligible pressure to a deployed volume between about 3 to about 5 milliliters requires an initially large and continuous change in pressure to overcome the resistance to stretching.
  • an immediate pressure change from zero or negligible pressure to between about 4 to 7 pounds per square inch (28 to 48 kilopascals) is needed to overcome the resistance to stretching needed to inflate such exemplary conventional retainer balloons to a volume of even 1 cubic centimeter
  • Integrating a pilot-balloon type indicator such as described by Fournie et al. or a bellows system or similar graduated indicator as previously described into the base of a low-profile PEG tube device which provides a continuous reading of the pressures encountered by such elastic balloons during stretching requires separating bars, indicator lines or similar components on the flexible membrane that provide information based on very small movements - typically less than one millimeter. Using such a small scale to provide a continuous reading of the inflationary state of the retainer balloon makes it difficult to read and view properly, especially at inflating pressure less than 4 pounds per square inch (less than 28 kilopascals).
  • the base of a typical low-profile PEG tube is approximately 1.625 inches (-41 mm) in length, approximately 0.75 inches (-19 mm) in width and approximately 0.5 inches (-13 mm) in depth.
  • FIG. 1 D which corresponds to FIG. 3 of Fournie, et al., comparing the relative dimensions of the pilot-balloon type indicator 15 located in the base 12 of the conventional PEG tube device 10 with the base dimensions noted above provides a context in which to understand that the small size of the pilot-balloon type indicator 15 would be impractical.
  • the pilot-balloon type indicator would appear to have dimensions of approximately 6 mm in length, approximately 5 mm in width and the separating bar on the indicator would appear to have a width of approximately 0.8 mm (about the diameter of the medium size ball-tip from the tip of a ball point pen or the diameter of a pencil lead from a mechanical pencil).
  • a pressure change indicator assembly that can be readily integrated into the head of a PEG tube and which is easy to view and read properly and function at pressures less than about 4 pounds per square inch (28 kilopascals).
  • the present invention provides a balloon catheter device incorporating an indicator that provides a discrete visual signal about the inflation condition of balloon that is associated with the catheter.
  • the indicator provides a discrete visual signal that the volume of the balloon is different from a predetermined volume.
  • the indicator may provide a discrete visual signal that the pressure of a fluid in the balloon is different from a predetermined level of pressure.
  • This present invention provides particular advantage for a balloon catheter device that incorporates a balloon having a predetermined fill volume at relatively low pressures (e.g., 4 pounds per square inch (28 kilopascals) or less).
  • the balloon catheter device may be an enteral feeding catheter assembly that includes a catheter having a proximal end, a distal end, and catheter walls defining a catheter lumen.
  • a base is located at the proximal end of the catheter.
  • the base defines an opening to the catheter lumen.
  • the base itself has a first end and a second end.
  • the assembly includes an inflatable balloon located at a distal end of the catheter.
  • a characteristic feature of the inflatable balloon is that is has a predetermined fill volume.
  • Such inflatable balloons are readily distinguishable from conventional elastic balloons (e.g., soft elastic silicone) typically used with enteral feeding catheters.
  • the predetermined fill volume is the same as or no more than about 1 .5 times (i.e., about 50 percent greater than) the volume achieved by expanding a balloon having an initially collapsed, folded, non-distended state to a state in which the material that forms the balloon is smooth and completely unfolded but prior to any meaningful stretching or distending of that material. That is, the predetermined fill volume is the same as or no more than about 1.5 times (i.e., about 50 percent greater than) the volume of the balloon at the transition from its non-distended state to its distended state.
  • the assembly includes an inflation valve located on the base.
  • the inflation valve is in fluid communication with the balloon. This may be accomplished through an inflation lumen, defined by a portion of the wall of the catheter, extending from the balloon to the inflation valve. An external inflation lumen or other configurations are contemplated.
  • the inflation valve may desirably be located on the first end of the base.
  • the assembly also includes a pre-biased indicator located on the base in fluid communication with the balloon.
  • the pre-biased indicator is configured to provide a discrete visual signal that the pressure of a fluid in the balloon has changed from a predetermined level of pressure.
  • the pre-biased indicator is configured to provide a discrete visual signal that the volume of the balloon has changed from a predetermined volume.
  • the pre-biased indicator may be configured to provide a discrete visual signal that the volume of the balloon is less than a predetermined fill volume.
  • the indicator may be located on the second end of the base. It is
  • the indicator may be located on the first end of the base.
  • the pre-biased indicator may be in fluid communication with the balloon through an indicator lumen, defined by a portion of the wall of the catheter, extending from the balloon to the indicator.
  • the pre-biased indicator may be in fluid communication with the balloon through the inflation lumen, defined by a portion of the wall of the catheter, extending from the balloon to the inflation valve and the indicator.
  • the pre-biased indicator of the enteral feeding catheter assembly may include a housing having a first end, a second end, one or more walls defining an interior channel, and an axial dimension.
  • the first end of the housing is in fluid communication with the inflatable balloon.
  • at least a portion of the housing is transparent or translucent.
  • the pre-biased indicator further includes a flexible sleeve positioned within the interior channel of the housing.
  • the flexible sleeve has a first surface, an opposed second surface, a first end located within the interior channel of the housing, a second end engaged with the housing to create a fluid impervious seal, and a flexible, generally annular portion joining the first end and second end of the sleeve.
  • the flexible, generally annular portion of the flexible sleeve defines a rolling annular fold intermediate the first end and the second end of the sleeve.
  • the rolling annular fold is configured so that at least a portion of the first surface of the flexible sleeve is generally adjacent the one or more housing walls and at least a portion of the second surface of the flexible sleeve defines a sleeve cavity.
  • the rolling annular fold travels as the sleeve moves in the axial direction of the housing. That is, movement of the flexible sleeve in an axial direction causes a portion of the second surface of the flexible sleeve to evert or turn inside out at the rolling annular fold so that it becomes directly adjacent the one or more housing walls.
  • the assembly also includes a biasing element located at least partially within the sleeve cavity and between the first end of the housing and the second end of the housing.
  • the biasing element is configured to deform at a defined force that corresponds to a predetermined fill volume so the flexible sleeve moves from a first axial position to at least a second axial position to provide a discrete visual signal that the pressure of a fluid in the balloon is different from an inflation pressure that corresponds to the predetermined fill volume.
  • the biasing element is a deformable device or component that distorts due to compressive forces yet recovers to its original shape when the compressive forces are removed.
  • the biasing element may be a spring, such as a coil spring, a plurality of springs, an elastomeric body or the like.
  • the biasing element may have a spring rate or a deformation rate or tripping point of between about 0.1 Ibs-force/inch to about 1 .0 lbs-force /inch (about 0.1 newtons/cm to about 1 .8 newtons/cm) which provides a discrete signal of change in pressure, particularly for pressures below about 4 pounds per square inch (psi) (about 28 kilopascals), for example, for pressures of from 1 to about 3.5 pounds per square inch (approximately 7 to about 25 kilopascals), or as another example, for pressures of from about 2 to about 3 pounds per square inch (approximately 14 to about 21 kilopascals).
  • the present invention also encompasses a balloon catheter device that is composed of a catheter having a proximal end, a distal end, and catheter walls defining a catheter lumen; a base located at the proximal end of the catheter defining an opening to the catheter lumen; an inflatable balloon having a predetermined fill volume, the balloon located at a distal end of the catheter and configured to contain a fluid under pressure; an inflation valve located on the base, the inflation valve in fluid communication with the balloon; and a pre-biased indicator in fluid communication with the balloon.
  • the pre-biased indicator is configured to provide a discrete visual signal that the pressure of a fluid in the balloon has changed from a predetermined level of pressure.
  • the pre-biased indicator is configured to provide a discrete visual signal that the volume of the balloon has changed from a predetermined volume.
  • the pre-biased indicator may be configured to provide a discrete visual signal that the volume of the balloon is less than a predetermined fill volume
  • the present invention encompasses an indicator assembly for use in medical devices having a balloon that contains a pressurized liquid.
  • the indicator assembly is especially for medical devices having a head located outside the human body and an inflatable retainer balloon for deployment within a lumen of a human body.
  • the indicator assembly includes an inflatable thin-walled balloon having a predetermined fill volume.
  • the balloon is configured to contain a fluid under pressure upon inflation to its predetermined fill volume and after inflation further configured to contain a reserve volume of fluid that is less than the predetermined fill volume when the fluid is no longer under pressure .
  • the pressure of the fluid upon inflation is at relatively low pressures (e.g., 4 pounds per square inch (28 kilopascals) or less).
  • the indicator assembly also includes a pre-biased indicator that provides only a first discrete visual signal when the balloon is inflated to its predetermined fill volume and a second discrete visual signal when the fluid in the balloon is no longer under pressure, with no signal of other inflation states therebetween. That is, the pre-biased indicator provides a signal of only two states of the balloon - that it is at its predetermined fill volume and that the fluid in the balloon is no longer under pressure. According to the invention, the second discrete visual signal provides warning that the balloon volume has reached the reserve volume - which generally corresponds to the volume of the balloon at the transition from its non- distended state to its distended state when the balloon is no longer under pressure or at about the lower limit of the predetermined fill volume.
  • the predetermined fill volume is desirably from about the reserve volume (i.e., just above the reserve volume) to about 1.5 times greater than the reserve volume (i.e., about the reserve volume to about 50 percent greater than the volume of the balloon at the transition from its non-distended state to its distended state).
  • the predetermined fill volume may be from about 1 .01 to about 1 .4 times greater than the reserve volume (i.e., about 1 percent to about 40 percent greater than the volume of the balloon at the transition from its non-distended state to its distended state).
  • the predetermined fill volume may be from about 1 .5 to about 1 .3 times greater than the reserve volume (i.e., about 5 percent to about 30 percent greater than the volume of the balloon at the transition from its non-distended state to its distended state).
  • fluid communication means a transmission or passage for a between two points and/or two structures for a specific purpose.
  • fluid communication would be a passage which permits liquids and/or gasses to pass.
  • Couple includes, but is not limited to, joining, connecting, fastening, linking, tying, adhering (via an adhesive), or associating two things integrally or interstitially together.
  • the term “configure” or “configuration”, and derivatives thereof means to design, arrange, set up, or shape with a view to specific applications or uses. For example: a military vehicle that was configured for rough terrain; configured the computer by setting the system's parameters.
  • the terms “substantial” or “substantially” refer to something which is done to a great extent or degree; a significant or great amount; for example, as used herein "substantially” as applied to “substantially” covered means that a thing is at least 70% covered.
  • align refers to the spatial property possessed by an arrangement or position of things in a straight line.
  • orientation or “position” used interchangeably herein refer to the spatial property of a place where something is situated or a way in which something is situated; for example, “the position of the hands on the clock.”
  • the term "about" adjacent to a stated number refers to an amount that is plus or minus ten (10) percent of the stated number.
  • non-distended catheter balloon when used with respect to a catheter balloon refers to a catheter balloon which has no radial pressure applied to the balloon's inner surface that is greater than atmospheric pressure or the pressure of the environment immediately surrounding the exterior of the balloon.
  • Non-distended catheter balloons include, for example, a catheter balloon which does not contain a fluid, or which contains a fluid that is not under pressure or a pressure that is less than or equal to atmospheric pressure or the pressure of the environment immediately surrounding the exterior of the balloon.
  • the term "distended" when used with respect to a catheter balloon refers to a catheter balloon which is being subjected to pressure applied to the balloon's inner surface that is greater than atmospheric pressure or the pressure of the environment immediately surrounding the exterior of the balloon, such as pressure exerted by a fluid (e g., pressurized liquid or gas) contained within the catheter balloon.
  • a fluid e g., pressurized liquid or gas
  • predetermined fill volume when used with respect to a catheter balloon refers to a volume in a range with a lower limit at the transition from a non-distended state to a distended state where the fluid in the balloon is first under pressure and a upper limit that is no more than about 1 .5 times (i.e., about fifty percent (50%) greater than) the volume of the balloon at the transition from a non-distended state to a distended state.
  • a predetermined fill volume can be the volume of the balloon at the transition from a non-distended state to a distended state and may encompass a volume of up to about 1.4 times (i.e., about forty percent (40%) greater than) the volume of the balloon at the transition from a non-distended state to a distended state.
  • a predetermined fill volume can be the volume of the balloon at the transition from a non-distended state to a distended state to a volume up to about 1.2 times (i.e., about twenty percent (20%) greater than) the volume of the balloon at the transition from a non-distended state to a distended state.
  • FIG. 1 A is a perspective view of an exemplary prior art device.
  • FIG. 1 B is a perspective view of an exemplary prior art device.
  • FIG. 1 C is an illustration of a feature of a conventional prior art device.
  • FIG. 1 D is a top view of a conventional prior art device.
  • FIG. 2A is a perspective view of an exemplary enteral feeding catheter assembly incorporating an indicator.
  • FIG. 2B is a perspective view of a detail of exemplary enteral feeding catheter assembly incorporating an indicator.
  • FIG. 3 is a side view showing a cross-section of an exemplary enteral feeding catheter assembly incorporating an indicator.
  • FIG. 4 is a perspective view showing a cross-sectional detail of a feature from an exemplary enteral feeding catheter assembly incorporating an indicator.
  • FIGS. 5A and 5B are perspective views showing cross-sectional details of a feature from an exemplary enteral feeding catheter assembly incorporating an indicator.
  • FIGS. 6A and 6B are perspective views showing details of an exemplary enteral feeding catheter assembly incorporating an indicator.
  • FIGS. 7A and 7B are illustrations of a feature of an exemplary enteral feeding catheter assembly incorporating an indicator.
  • the invention(s) disclosed herein relate generally to improved medical care for patients who require enteral feeding. More particularly, the invention(s) disclosed herein relate to an enteral feeding assembly including an inflatable balloon having a predetermined fill volume for holding at least a portion of the assembly in a body lumen and further incorporating an indicator that provides a discrete visual signal that pressure in the balloon is different from a predetermined level of pressure.
  • the invention(s) disclosed herein may also include an indicator assembly for use with medical devices incorporating inflatable balloons in which the indicator assembly including an inflatable balloon having a predetermined fill volume and further incorporating an indicator that provides a discrete visual signal that pressure in the balloon is different from a predetermined level of pressure.
  • FIGS. 2A though 7B An enteral feeding catheter assembly 20 incorporating a pre- biased indicator 22 that provides a discrete visual signal that pressure in a balloon 24 associated with the catheter 26 is different from a predetermined level of pressure.
  • the pre-biased indicator 22 may be configured to provide a discrete visual signal that the volume of the balloon 24 has changed from a predetermined volume.
  • the pre-biased indicator 22 may be configured to provide a discrete visual signal that the volume of the balloon 24 is less than a predetermined fill volume.
  • the enteral feeding catheter assembly 20 includes a catheter 26 having a proximal end 28, a distal end 30, and catheter walls 32 defining a catheter lumen 34.
  • a base 36 is located at the proximal end 28 of the catheter 26.
  • the base 36 defines an opening 40 to the catheter lumen 34.
  • the base itself has a first end 42 and a second end 44.
  • the assembly 10 includes an inflatable balloon 24 located at a distal end of the catheter.
  • a characteristic feature of the inflatable balloon 24 is that it has a predetermined fill volume. As noted above, such inflatable balloons having a predetermined fill volume are readily distinguishable from conventional elastic balloons. Generally speaking, during expansion of a balloon having an initially collapsed or crumpled state as generally illustrated in FIG.
  • the predetermined fill volume is a volume in a range having a lower limit at the volume in which the material that forms the balloon is first becomes smooth, unfolded and under a pressure but prior to any stretching or distending of that material and an upper limit that is no more than 50% greater in volume than the lower limit.
  • the predetermined fill volume is a volume in a range with a lower limit at the balloon's transition from a non-distended state to a distended state and a upper limit that is no more than about 1 .5 times (i.e., about fifty percent (50%) greater than) the volume of the balloon at the transition from a non-distended state to a distended state.
  • the volume at the lower limit of this range where the pressure of the fluid in the balloon is essentially zero is the "reserve volume”.
  • the assembly 20 includes an inflation valve 46 located on the base.
  • the inflation valve 46 is in fluid communication with the balloon 24. This may be accomplished through an inflation lumen 48, defined by a portion of the wall 32 of the catheter 26, extending from the balloon 24 to the inflation valve 46.
  • An external inflation lumen or other configurations are contemplated.
  • the inflation valve may desirably be located on the first end 42 of the base.
  • the pre-biased indicator 22 is located on the base 36 in fluid
  • the pre-biased indicator 22 is configured to provide a discrete visual signal that the pressure of a fluid in the balloon has changed from a predetermined level of pressure.
  • the pre-biased indicator 22 may be configured to provide a discrete visual signal that the volume of the balloon 24 has changed from a predetermined volume.
  • the pre-biased indicator 22 may be configured to provide a discrete visual signal that the volume of the balloon 24 is less than a predetermined fill volume.
  • the indicator 22 may be located on the second end 44 of the base 36. It is contemplated that the indicator 22 may be located on the first end 42 of the base fitted in parallel with the inflation valve 46 or in some other arrangement.
  • the pre- biased indicator 22 may be in fluid communication with the balloon 24 through an indicator lumen 50, defined by a portion of the wall 32 of the catheter 26, extending from the balloon 24 to the indicator 22.
  • the pre- biased indicator may be in fluid communication with the balloon through the inflation lumen, defined by a portion of the wall of the catheter, extending from the balloon to the inflation valve and the indicator.
  • the pre-biased indicator 22 includes a housing 52.
  • the housing 52 may be formed of one-piece.
  • the housing 52 may be composed of multiple sections.
  • the housing 52 may be formed of a lens 54 and a cap 56.
  • the housing 52 has a first end 58, a second end 60, one or more walls 62 defining an interior channel 64, and an axial dimension "A".
  • the first end 58 of the housing 52 is in fluid communication with the inflatable balloon 24.
  • at least a portion of the housing 52 is transparent or translucent.
  • the lens 54 may be transparent or translucent.
  • the pre-biased indicator 22 further includes a flexible sleeve 66 positioned within the interior channel 64 of the housing 52.
  • the flexible sleeve 66 has a first surface 68, an opposed second surface 70, a first end 72 located within the interior channel of the housing, a second end 74 engaged with the housing 52 to create a fluid impervious seal, and a flexible, generally annular portion 76 joining the first end 72 and second end 74 of the sleeve.
  • the flexible, generally annular portion 76 of the flexible sleeve defines a rolling annular fold 78 intermediate the first end 72 and the second end 74 of the sleeve.
  • the rolling annular fold 78 is configured so that at least a portion of the first surface 68 of the flexible sleeve is generally adjacent the one or more housing walls 62 and at least a portion of the second surface 70 of the flexible sleeve defines a sleeve cavity 80.
  • the rolling annular fold 78 travels or moves as the first end 72 of the sleeve 66 travels along the axial direction or dimension "A" of the housing 52.
  • the pre-biased indicator 22 also includes a biasing element 82 located at least partially within the sleeve cavity 80 and between the first end 58 of the housing and the second end 60 of the housing.
  • the biasing element 82 is configured to deform at a predetermined pressure or force so the flexible sleeve 72 moves from a first axial position to at least a second axial position. The pressure or force is applied against the first end 72 of the flexible sleeve 66.
  • the first end 72 is in fluid communication with the inflatable balloon through an indicator lumen or, in some configurations, an inflation lumen. A detail of this movement of the flexible sleeve is illustrated in cross-sectional view by FIG. 5A and FIG. 5B.
  • FIG. 5A illustrates a cross section of a flexible sleeve 66 showing the biasing element 82 located at least partially within the sleeve cavity 80 defined by the flexible annular portion 76 prior to deformation of the biasing element.
  • the first end 72 of the flexible sleeve 66 is at a first axial position "P".
  • the second end 74 of the flexible sleeve 66 is near the rolling annular fold 78 and is relatively distant from the first end 72 of the sleeve 66.
  • FIG. 5B illustrates a cross section of a flexible sleeve 72 showing the biasing element 82 located at least partially within the sleeve cavity 80 defined by the flexible annular portion 76 after deformation of the biasing element.
  • the first end 72 of the flexible sleeve 66 is at a second axial position "D".
  • the second end 74 of the flexible sleeve 66 is relatively further away from the rolling annular fold 78 and is relatively nearer to the first end 72 of the sleeve 66.
  • a user utilizes a syringe to add sterile water or some other appropriate liquid, or in some situations, air, through the inflation valve to fill the balloon.
  • the biasing element 82 of the pre- biased indicator deforms due to force (i.e., fluid pressure) against the first end 72 of the flexible sleeve communicated from the balloon through the indicator lumen (or, in some configurations, the inflation lumen). That fluid pressure is generated by filling the balloon past the "reserve volume" at the transition from its non- distended state to its distended state at which point the pressure of fluid in the balloon increases, typically in a linear pressure-volume relationship, until the pressure of the balloon reached the predetermined level of pressure at which the biasing element deforms.
  • the predetermined level of pressure corresponds to the predetermined fill volume, which is a volume in a range with a lower limit at the volume of the balloon at the transition from its non-distended state to its distended state where the fluid in the balloon is first under pressure and an upper limit no more than about 1 .5 times (i.e., 50 percent greater than) the volume of the balloon at the transition from its non-distended state to its distended state.
  • FIG. 6A illustrates an enteral feeding catheter assembly 20 incorporating a pre-biased indicator 22.
  • the biasing element is deformed due to pressure in the inflatable balloon (not shown in this FIG. 6A) so the flexible sleeve is not visible in the pre-biased indicator 22.
  • the flexible sleeve 66 is in the second axial position "D" as generally illustrated in FIG. 5B.
  • the cap 56, the flexible sleeve 66 and the biasing element 82 are sized so that the flexible sleeve 66 is not visible through the cap 56, which desirably is opaque, when the flexible sleeve is in the second axial position "D".
  • This movement of the flexible sleeve to the second axial position "D" where it is not readily visible provides a very simple and reliable indication to a user that the pressure of fluid in the balloon is different from (i.e., above) a predetermined level of pressure.
  • the movement of the flexible sleeve to the second axial position "D" where it is not readily visible provides a very simple and reliable indication to a user that the volume of the balloon is at or greater than a predetermined fill volume.
  • a vent means 96 to maintain atmospheric pressure in the sleeve cavity 80 defined by the flexible annular portion 76 of the flexible sleeve is located at the second end of the housing 60.
  • the vent means 96 may be a hole, a plurality of holes, a slit, a plurality of slits, a highly porous, spongy region or the like.
  • the vent means 96 allows passage of air into and out of the sleeve cavity 80 defined by the second surface 70 of the flexible sleeve at the flexible annular portion 76 located in the interior channel 64 of the housing 52.
  • the passage of air through the vent means 96 is in response to the axial movement of the flexible sleeve.
  • the flexible sleeve may include a plate 90 joined to a plug 92 that is adapted to fit into a socket 94 formed in the first end 72 of the flexible sleeve.
  • This plate and the associated plug and socket may be used to provide some dimensional stability to the first end 72 of the flexible sleeve which is in fluid communication with the balloon and which receives pressure that is communicated to the biasing element.
  • the plate 90 may also be configured to have the same color as the material at the second end 60 of the housing 52 (e.g., the cap 56 if a two piece housing is used) so that, when the biasing element is deformed and the flexible sleeve is at its second axial position "D", the material forming the first end 72 of the flexible sleeve is not readily visible because it is hidden beneath the plate 90 and blends in with the second end 60 of the housing 52 so that a user does not misinterpret the position of the sleeve based on the visible presence of the color of the material forming the flexible sleeve.
  • FIG. 6B there is illustrated an enteral feeding catheter assembly 20 incorporating a pre-biased indicator 22 in a different configuration.
  • the biasing element 82 of the pre-biased indicator 22 is no long deformed due to pressure in the inflatable balloon (not shown in this FIG. 6A).
  • the flexible sleeve is visible through the housing and provides a simple, easy to interpret signal. More particularly, the flexible sleeve 66 is in the first axial position "P" as generally illustrated in FIG. 5A.
  • the housing 52 is composed of two or more pieces such as, for example, a lens 54 and a cap 56, these components and the flexible sleeve 66 and the biasing element 82 are sized so that the flexible sleeve 66 is visible through the lens 54, which desirably is transparent or translucent, when the fluid pressure in the balloon falls below a predetermined level and the biasing element 82 expands to urge the first end 72 of flexible sleeve 66 back along the interior channel 64 to the first end 58 of the housing 52.
  • the biasing element pushes the flexible sleeve back into the first axial position where a user can see the flexible sleeve and readily understand the signal that the pressure in the balloon has fallen below the predetermined level.
  • This movement of the flexible sleeve to the first axial position "P" where it is readily visible provides a very simple and reliable indication to a user that the pressure of fluid in the balloon is different from (i.e., below) a predetermined level of pressure.
  • the movement of the flexible sleeve to the first axial position "P" where it is readily visible provides a very simple and reliable indication to a user that the volume of the balloon is below or less than a predetermined fill volume.
  • the flexible sleeve is desirably made of a soft, flexible material.
  • exemplary materials include, but are not limited to, polyurethane, silicone and other materials that are resilient.
  • the material has a memory of its shape.
  • Suitable materials include, but are not limited to, "soft” or elastomeric medical grade silicone polymers and "soft” or elastomeric medical grade polyurethane polymers.
  • the "soft” polymers may have a Shore A Hardness of between about 20 and about 60, more desirably between about 30 and about 50.
  • the Shore Hardness testing of soft plastics is most commonly measured by the Shore (Durometer) test using either the Shore A or Shore D scale.
  • the Shore A scale is used for "softer” rubbers while the Shore D scale is used for "harder” ones.
  • the Shore A Hardness is the relative hardness of elastic materials such as rubber or soft plastics can be determined with an instrument called a Shore A Durometer. If the indenter completely penetrates the sample, a reading of 0 is obtained, and if no penetration occurs, a reading of 100 results. The reading is dimensionless.
  • the Shore hardness is measured with an apparatus known as a Durometer and is sometimes also referred to as Durometer Hardness.
  • the hardness value is determined by the penetration of the Durometer indenter foot into the sample. Because of the resilience of rubbers and plastics, the hardness reading may change over time so the indentation time is sometimes reported along with the hardness number.
  • the ASTM test number is ASTM D2240 while the analogous ISO test method is ISO 868.
  • the flexible sleeve may have a color or pigment integrated into the material forming the sleeve.
  • the flexible sleeve may have a coating or layer of color on the exterior of the sleeve or on the interior of the sleeve.
  • the flexible sleeve may incorporate or be coated with a generally bright, fluorescent color that is readily visible and easy to identify.
  • Examples of these colors include, but are not limited to, yellow, orange, blue, green, red, purple and various intensities and combinations thereof.
  • the flexible sleeve may have a first color such as, for example, green, appearing at its second surface 70 and a second color such as, for example, red, appearing at its first surface 68.
  • the housing 52 may be transparent such that when the flexible sleeve is at the second axial position "D", the flexible sleeve everts at the rolling annular fold 78 such that the color of the second surface 70 (e.g., green) is primarily visible and the color of the first surface 68 (e.g., red) is minimally visible or not visible.
  • This movement of the flexible sleeve to the second axial position "D" where the color of the second surface 70 (e.g., green) is primarily visible and the color of the first surface 68 (e.g., red) is minimally visible or not visible provides a very simple and reliable indication to a user that the pressure of fluid in the balloon is different from (i.e., above) a predetermined level of pressure.
  • the movement of the flexible sleeve to the second axial position "D" where the color of the second surface 70 (e.g., green) is primarily visible and the color of the first surface 68 (e.g., red) is minimally visible or not visible provides a very simple and reliable indication to a user that the volume of the balloon is at or greater than a predetermined fill volume.
  • the housing 52 may be transparent such that when the flexible sleeve is at the first axial position "P", the flexible sleeve everts at the rolling annular fold 78 such that the color of the second surface 70 (e.g., green) is minimally visible or not visible and the color of the first surface 68 (e.g., red) is primarily visible.
  • the color of the second surface 70 e.g., green
  • the color of the first surface 68 e.g., red
  • This movement of the flexible sleeve to the first axial position "P" where the color of the second surface 70 (e.g., green) is minimally visible or not visible and the color of the first surface 68 (e.g., red) is primarily visible provides a very simple and reliable indication to a user that the pressure of fluid in the balloon is different from (i.e., below) a predetermined level of pressure.
  • the movement of the flexible sleeve to the first axial position "P" where the color of the second surface 70 (e.g., green) is minimally visible or not visible and the color of the first surface 68 (e.g., red) is primarily visible provides a very simple and reliable indication to a user that the volume of the balloon is below or less than a predetermined fill volume.
  • the flexible sleeve 66 and the other components of the pre-biased indicator 22 may be sized to appropriately fit with the head 36 of the enteral feeding assembly 20.
  • the flexible sleeve 66 may have a length from the first end 72 to the furthest outward extent of the rolling annular fold 78 towards the second end 60 of the housing 52 that may range from about 6mm to about 12mm.
  • the indicator sleeve may have a length from the first end 72 to the furthest extent of the rolling annular fold 78 of from about 7mm to about 1 1 mm.
  • the indicator sleeve may have a length from the first end 72 to the furthest extent of the rolling annular fold 78 of from about 8mm to about 10mm.
  • the diameter of the flexible sleeve may be from about 2mm to about 10mm.
  • the diameter of the flexible sleeve may be from about 3mm to about 9mm.
  • the diameter of the flexible sleeve may be from about 4mm to about 6mm.
  • the diameter implies a circular cross-section, other cross-sectional geometries are contemplated.
  • the flexible sleeve may have an elliptical cross-section, oval cross section or even a hexagonal cross- section, an octagonal cross-section or the like provided such cross-sectional geometries do not interfere with the movement of the rolling annular fold or rolling annular-like fold in the case of non-circular geometries.
  • rolling annular fold encompasses rolling annular-like folds that are based on non-circular geometries to the extent that such geometries allow the rolling fold to evert the flexible sleeve and function as described above.
  • the diameter of the flexible sleeve need not be uniform.
  • the diameter of the flexible sleeve may be smaller at the first end 72 of the flexible sleeve and larger towards the second end 74 of the flexible sleeve closer to the rolling annular fold 78 provided such a change in diameter does not interfere with the function of the rolling annular fold.
  • Other non- uniformities of the flexible sleeve are contemplated provided they do not interfere with the operation of the sleeve and the rolling annular fold.
  • the flexible sleeve may be configured to travel between about 3 to about 10mm. That is, the displacement of the first end 72 of the flexible sleeve from its first axial position "P" to its second axial position “D” may range from about 3 to about 10mm. The larger distance provides greater visibility of the flexible sleeve and a more noticeable signal. The smaller distance provides for an even more compact pre-biased indicator.
  • the displacement of the first end 72 of the flexible sleeve from its first axial position "P" to its second axial position “D” may range from about 4 to about 7mm.
  • the displacement of the first end 72 of the flexible sleeve from its first axial position "P” to its second axial position “D” may range from about 4 to about 5mm.
  • the biasing element 82 is desirably a spring such as, for example, a coil compression spring. It is contemplated that other resilient constructions could be used as the biasing element. These include flexible, resilient foams, metal strips, volute or secateur springs, conical springs and the like. Descriptions of conical springs may be found at, for example, U.S Patent No. 4, 1 1 1 ,407 for "Conical Compression Spring". Generally speaking, the biasing element 82 is desirably a coil compression spring that may be characterized as having linear movement and a spring rate designed such that the spring rapidly deforms over a very small range of pressure to provide a very discrete signal that the pressure of a fluid in the balloon is different from the predetermined pressure of the spring.
  • the biasing element may desirably be sized so that it approaches full compression or solid compression (including any allowance for coil clash or similar property for other resilient structures) at a point at or just beyond which the flexible sleeve reaches its second axial position "D".
  • the biasing element is sized so that it approaches solid compression or full compression at a point which allows the flexible sleeve to compress sufficiently so it reaches its second axial position "D" and become hidden from view in the second end 60 of the housing 52 while providing a column of support for the flexible sleeve 66 so that the travel of the flexible sleeve much beyond the second axial position "D" is limited.
  • This characteristic serves to prevent the flexible sleeve from extending far enough to the second end 60 of the housing to totally evert or flip inside-out and eliminate the rolling annular fold 78. If the rolling annular fold is eliminated, the indicator may fail to function properly and may fail to allow travel of the flexible sleeve 66 back to its first axial position "P" in response to pressure of fluid in the balloon that is lower than the predetermined level of pressure of the biasing element because the inverted flexible sleeve may provide sufficient resistance to the biasing element to keep it from reforming or reconstituting the rolling annular fold.
  • the biasing element allows ease of motion in both directions between the first axial position "P" and the second axial position "D" so the flexible sleeve can rapidly respond if the pressure of fluid in the balloon deviates from the predetermined level of pressure of the biasing element.
  • the biasing element is desirably configured so that the change in axial position of the flexible sleeve that generates the discrete visual signal occurs over a relatively small change in the pressure of the fluid in the balloon.
  • the change in pressure sufficient to effect the change in axial position of the flexible sleeve may be between about 0.25 pounds per square inch and about 0.75 pound per square inch.
  • the change in pressure sufficient to effect the change in axial position of the flexible sleeve may be between about 0.4 pounds per square inch and about 0.6 pound per square inch.
  • the change in pressure sufficient to effect the change in axial position of the flexible sleeve may be about 0.5 pounds per square inch (approximately 3.5 kilopascals). This change in pressure is a change in relative pressure and represents a change in pressure relative to the surrounding ambient or atmospheric pressure.
  • the spring rate of the biasing element is a linear spring rate and is expressed in terms of pounds-force per linear inch (Ibs-force/inch). That is, the spring rate is the load, expressed in pounds-force, required to deflect (i.e., compress or expand) the spring by a distance of one inch. For example, if the spring rate is forty (40) Ibs-force/inch, it would take ten (10) lbs-force to deflect (i.e., compress or expand) the spring 0.25 inch and it would take eighty (80) lbs- force to deflect (i.e., compress or expand) the spring two (2) inches. One (1 ) Ib- force/inch is about 1 .8 newtons/cm.
  • the spring rate may range from about 0.1 Ibs- force/inch to about 1.0 lbs-force /inch (about 0.4 newtons/inch to about 4.5 newtons/inch or about 0.1 newtons/cm to about 1 .8 newtons/cm). Desirably, the spring rate may range from about 0.13 Ibs-force/inch to about 0.60 Ibs-force/inch. More desirably, the spring rate may range from about 0.2 Ibs-force/inch to about 0.45 Ibs-force/inch. Even more desirably, the spring rate may range from about 0.25 Ibs-force/inch to about 0.35 Ibs-force/inch. For example, the spring rate may be about 0.3 Ibs-force/inch.
  • the flexible sleeve 66 should have sufficient softness that it does not meaningfully interfere with the spring rate.
  • the flexible sleeve may have a flexible, generally annular portion in which the thickness of the walls in that portion range from about 5 to about 30 mils (i.e., about 5 to about 30 thousandths of an inch or about 127 micrometers to about 760 micrometers).
  • the thickness of the walls may range from about 10 to about 20 mils (i.e., about 250 micrometers to about 510 micrometers).
  • the thickness of the walls may range from about 15 to about 20 mils (i.e., about 380 micrometers to about 510 micrometers).
  • This thickness may be determined by conventional techniques using a digital contact device such as, for example a Mitutoyo Litematic Digimatic Measuring Unit in accordance with the appropriate standardized tests.
  • a digital contact device such as, for example a Mitutoyo Litematic Digimatic Measuring Unit in accordance with the appropriate standardized tests.
  • the thickness of the flexible sleeve may be selected to meaningfully complement the resistance of the biasing element to deformation to provide a combined predetermined pressure of deformation for the combination of the two components.
  • An important feature of the present invention is that it provides a discrete visual signal that the pressure of a fluid in an inflatable balloon is different from a predetermined level of pressure.
  • this is accomplished by having the biasing element selected to provide sufficient movement (e.g., linearly along the axial dimension of the housing) and responsiveness to pressure (e.g., a low spring rate) such that the biasing element rapidly deforms over a very small range of pressure change to provide a discrete, distinct signal that the pressure of a fluid in the balloon is different from the predetermined pressure of the biasing element and/or that the volume of the balloon is different from the predetermined fill volume.
  • Such a discrete visual signal may be characterized as a "binary" signal.
  • the pressure is either greater than (or equal to) the predetermined level of pressure which provides one output from the pre-biased indicator or the pressure is lower than the predetermined level of pressure which provides a different output from the pre-biased indicator.
  • the volume of the balloon is either greater than or equal to the predetermined fill volume which provides one output from the pre-biased indicator or the volume of the balloon is lower than the predetermined fill volume which provides a different output from the pre-biased indicator.
  • a predetermined fill volume is a volume in a range with a lower limit at the volume of the balloon at the transition from its non-distended state to its distended state where the fluid in the balloon is first under pressure and an upper limit no more than about 1.5 times (i.e., 50 percent greater than) the volume of the balloon at the transition from its non-distended state to its distended state.
  • balloons are markedly different from conventional elastic balloons made of materials that stretch from a relaxed or un-stretched condition to continuously stretch or distend under increasingly higher pressures to ten times to even twenty times or more of their initial un-stretched dimensions to reach a design fill volume of three (3) to five (5) milliliters and a maximum fill volume that typically ranges between about eight (8) to about ten (10) milliliters.
  • such elastic balloons may be overfilled to reach much greater volumes without significant build up in pressure to provide resistance to overfilling because of the elastic stretching of the material of the balloon.
  • FIG. 1 C an exemplary relationship between pressure and volume during the inflation of an elastic retainer balloon made of conventional "soft" or elastomeric medical grade silicone is illustrated in FIG. 1 C.
  • an immediate pressure change from zero or negligible pressure to between about 4 to 7 pounds per square inch (28 to 48 kilopascals) is needed to continuously stretch such exemplary conventional retainer balloons to a volume of even 1 milliliter.
  • a pressure between about 5 to 10 pounds per square inch (34 to 69 kilopascals) is needed to continuously stretch such conventional "soft" or elastomeric medical grade silicone balloons to a volume of about 3 milliliters.
  • FIG. 1 C While it may be possible to make some alterations to the distension or stretch characteristics of such conventional elastic balloons by modifying properties of the elastomeric materials or the thicknesses of the balloon walls, the pressure and volume relationship illustrated by FIG. 1 C is generally representative. It is notable that the pressure and volume relationship can be characterized as non-linear. Another important characteristic of such conventional "soft" or elastomeric balloons is that energy used to stretch the material of the balloon ten times or even twenty times or more of its initial un-stretched dimensions is retained or stored by the stretched elastomeric material. That stretched material exerts a retraction or recovery force that seeks to take the dimensions of the balloon substantially or completely back to its original un-stretched dimensions. Accordingly, if there is a leak or breach in the balloon or in another part of the system allowing fluid to escape, the pressure against the fluid in the balloon generated by the material of the balloon as it retracts will tend to empty the balloon very quickly.
  • the present invention employs the use of an inflatable balloon having a "predetermined fill volume" as defined above.
  • Such balloons are expandable from an initially collapsed or non-distended state to reach a predetermined volume without any meaningful stretching or distending of the materials that form the balloon unlike conventional elastic balloons that require continuously increasing pressure to stretch ten times to even twenty times or more of their initial un- stretched dimensions and then recover substantially or completely to their original un-stretched dimensions as that pressure is removed.
  • the predetermined fill volume is the volume of the balloon in a range with a lower limit at the volume of the balloon at the transition from its non-distended state to its distended state where the fluid in the balloon is first under pressure and an upper limit no more than about 1 .5 times (i.e., 50 percent greater than) the volume of the balloon at the transition from its non-distended state to its distended state.
  • elastic balloons lack a transition from a non-distended state to a distended state. If such a transition did exist, it would occur only during the earliest introduction of pressure to initiate stretching or continuous distension of the material of the balloon and would be far below the final deployed volume of the balloon.
  • an inflatable balloon having a predetermined fill volume is essentially an impervious, flexible bag or container having a relatively fixed size (i.e., fixed volume).
  • the balloon i.e., bag
  • Filling is accomplished by introducing fluid into the balloon through the inflation valve of the enteral feeding assembly.
  • the balloon transforms from a collapsed state to a distended state that generally corresponds to the particular distended profile of a balloon typically generated during the manufacture of the balloon in a molding, blowing, casting or similar process.
  • Various materials may used to form the inflatable balloon having a predetermined fill volume. These materials include, but are not limited to, polyurethane (PU), low-density polyethylene (LDPE), polyvinyl chloride (PVC), polyamide (PA), or polyethylene teraphthalate (PETP). Additionally, copolymer admixtures for modifying the characteristics of the material may be used, for example a low density polyethylene and ethylene-vinylacetate copolymer (LDPE- EVA), or blends of the above mentioned materials (e.g. PU with PVC or PU with PA) would be considered suitable for forming the inflatable balloon having a predetermined fill volume.
  • PU polyurethane
  • LDPE low-density polyethylene
  • PVC polyvinyl chloride
  • PA polyamide
  • PETP polyethylene teraphthalate
  • copolymer admixtures for modifying the characteristics of the material may be used, for example a low density polyethylene and ethylene-vinylacetate copolymer (LD
  • the balloons may have thin walls desirably in a range of between about 5 to about 50 micrometers, even more desirably, between about 5 to about 25 micrometers. Suitable materials should possess properties enabling them to be processed into an inflatable retention balloon having micro thin walls which do not deform elastically to such a degree that they are enabled to slip through the an opening. In contrast, conventional silicone balloons have wall thicknesses of about 250 micrometers or even greater.
  • FIGS. 7A and 7B are illustrations showing exemplary relationships between the balloon volume and the pressure of a fluid inside a balloon having a predetermined fill volume. These illustrations show the transition between the non- distended state and distended state of such as balloon.
  • FIG. 7A illustrates the relationship between pressure and volume for five samples of balloons having a predetermined fill volume of approximately two (2) milliliters.
  • the pressure profiles are essentially negligible during filling of the balloons to their predetermined fill volumes.
  • the slight pressure that is encountered is due to the driving force needed to get the fluid through the inflation lumen and to unfold the collapsed balloon.
  • the pressures begins to increase linearly.
  • FIG. 7B illustrates the relationship between pressure and volume for seven samples of balloons having a predetermined fill volume of approximately 5 milliliters.
  • the pressure profiles are essentially negligible during filling of the balloons to their predetermined fill volumes.
  • the slight pressure that is encountered is due to the driving force needed to get the fluid through the inflation lumen and to unfold the collapsed balloon.
  • the pressures begins in to increase linearly.
  • the deformation pressure of the pre-biased indicator may be set much lower than would be possible for conventional elastic balloons which must continually distend under increasing pressure.
  • the pre-biased indicator responds to the change in pressure that begins at the transition from the non-distended state to the distended state.
  • the predetermined level of pressure which corresponds to the predetermined fill volume of the balloon may be set at the transition from the non-distended state to the distended state or it may be set to a pressure that corresponds to a volume not more than about fifty percent (50%) greater.
  • the pre-biased indicator provides a discrete visual signal that the predetermined fill volume has been reached.
  • the pre- biased indicator provides a discrete visual signal that the balloon has lost pressure or volume and may be leaking.
  • An aspect of the present invention encompasses an indicator assembly for use in medical products, especially medical products having a head located outside the human body and an inflatable retainer balloon for deployment within a lumen of a human body.
  • the indicator assembly includes an inflatable thin-walled balloon having a predetermined fill volume.
  • a thin- wall balloon formed of a material such as, for example, polyurethane lacks rigidity sufficient for the balloon to serve as an anchor when it does not contain fluid such as a liquid or, in some situations, a gas.
  • this can correspond to balloons having thin walls with a thickness of about 100 micrometers or less.
  • the balloons have a wall thickness of about 50 micrometers or less. More desirably, the balloons have a wall thickness between about 5 to about 50 micrometers, more desirably between about 5 to about 25 micrometers, even more desirably, between about 5 to about 15 micrometers.
  • the balloon is configured to contain a fluid under pressure upon inflation to its predetermined fill volume and after inflation further configured to contain a reserve volume of fluid when the fluid is no longer under pressure.
  • the reserve volume is less than the predetermined fill volume and reflects a volume of liquid that is retained in the balloon at about the transition from its non-distended state to its distended state. This relationship or characteristic is illustrated by FIGS. 7A and 7B as discussed above.
  • the pressure of the fluid upon inflation to the predetermined fill volume is at relatively low pressures such as, for example, 4 pounds per square inch (28 kilopascals) or less.
  • the pressure of the fluid upon inflation to the predetermined fill volume may be between about 1 to about 3.5 pounds per square inch (psi) (approximately 7 to about 25 kilopascals).
  • the pressure of the fluid upon inflation to the predetermined fill volume may be between about 2 to about 3 pounds per square inch (psi) (approximately 14 to about 21 kilopascals).
  • the indicator assembly also includes an indicator that provides only a first discrete visual signal when the balloon is inflated to its predetermined fill volume and a second discrete visual signal when the fluid in the balloon is no longer under pressure, with no signal of other inflation states therebetween. That is, the indicator provides a signal of only two states of the balloon - that it is at its predetermined fill volume and that the fluid in the balloon is no longer under pressure.
  • the general structure of an exemplary indicator is described above and is illustrated at, for example, in FIGS. 2-4, 5A, 5B, 6A and 6B.
  • the second discrete visual signal provides warning that the balloon volume has reached the reserve volume. Because the balloon is configured to hold a volume of fluid even when the balloon is not under pressure (unless there is a catastrophic failure of the wall of the balloon or connection between the balloon and the device), a user will have a period of time to re-inflate the balloon or replace the device without having to worry about the balloon immediately failing to anchor the device.
  • the predetermined fill volume is desirably from about 1.01 to about 1 .5 times greater than the reserve volume (i.e., about 1 percent to about 50 percent greater than the volume of the balloon at the transition from its non-distended state to its distended state).
  • the predetermined fill volume may be from about 1.05 to about 1 .4 times greater than the reserve volume (i.e., about 5 percent to about 40 percent greater than the volume of the balloon at the transition from its non-distended state to its distended state).
  • the predetermined fill volume may be from about 1 .1 to about 1.3 times greater than the reserve volume (i.e., about 10 percent to about 30 percent greater than the volume of the balloon at the transition from its non-distended state to its distended state).

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
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  • General Physics & Mathematics (AREA)
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  • Gastroenterology & Hepatology (AREA)
  • Emergency Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention porte sur un ensemble de cathéter (20) incorporant un indicateur pré-sollicité (22), l'ensemble comprenant un cathéter (26) ayant une extrémité proximale (28), une extrémité distale (30), et des parois de cathéter (32) définissant une lumière de cathéter (34). L'ensemble comprend en outre une base (36) localisée au niveau de l'extrémité proximale (28) du cathéter, la base définissant une ouverture pour la lumière de cathéter, la base ayant une première extrémité (42) et une seconde extrémité (44). Un ballon gonflable (24) ayant un volume de remplissage prédéterminé est placé à l'extrémité distale (30) du cathéter. Une soupape de gonflage (46) est placée sur la base (36), la soupape de gonflage étant en communication fluidique avec le ballon par l'intermédiaire d'une lumière de gonflage (48) définie par les parois du cathéter (32). L'indicateur pré-sollicité placé sur la base et en communication fluidique avec le ballon est configuré pour fournir un signal visuel discret indiquant que la pression d'un fluide dans le ballon est différente d'un niveau prédéterminé de pression ou que le volume du ballon est différent du volume de remplissage prédéterminé.
PCT/IB2010/055341 2009-12-23 2010-11-22 Ensemble cathéter à introduction entérale incorporant un indicateur WO2011077286A1 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
EP10798192.0A EP2515825B1 (fr) 2009-12-23 2010-11-22 Ensemble cathéter à introduction entérale incorporant un indicateur
MX2012007430A MX338783B (es) 2009-12-23 2010-11-22 Ensamble de cateter de alimentacion enteral incorporando un indicador.
JP2012545484A JP5809639B2 (ja) 2009-12-23 2010-11-22 インジケータを備えた経腸栄養カテーテルアセンブリ
CN201080059225.4A CN102665646B (zh) 2009-12-23 2010-11-22 带指示器的肠饲导管组件
BR112012015019A BR112012015019A2 (pt) 2009-12-23 2010-11-22 conjunto de cateter de alimentação enteral incorporando em indicador
CA2781494A CA2781494C (fr) 2009-12-23 2010-11-22 Ensemble catheter a introduction enterale incorporant un indicateur
RU2012131060/15A RU2561047C2 (ru) 2009-12-23 2010-11-22 Блок катетера энтерального питания, включающий индикатор
KR1020127016305A KR101743015B1 (ko) 2009-12-23 2010-11-22 지시기를 포함하는 경장 공급 카테터 조립체
ES10798192.0T ES2589779T3 (es) 2009-12-23 2010-11-22 Conjunto de catéter de nutrición enteral que incorpora un indicador
AU2010334500A AU2010334500B2 (en) 2009-12-23 2010-11-22 Enteral feeding catheter assembly incorporating an indicator

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/645,553 US9132064B2 (en) 2009-12-23 2009-12-23 Enteral feeding catheter assembly incorporating an indicator
US12/645,553 2009-12-23

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WO2011077286A1 true WO2011077286A1 (fr) 2011-06-30

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US (2) US9132064B2 (fr)
EP (2) EP2515825B1 (fr)
JP (1) JP5809639B2 (fr)
KR (1) KR101743015B1 (fr)
CN (1) CN102665646B (fr)
AU (1) AU2010334500B2 (fr)
BR (1) BR112012015019A2 (fr)
CA (1) CA2781494C (fr)
ES (1) ES2589779T3 (fr)
MX (1) MX338783B (fr)
RU (1) RU2561047C2 (fr)
WO (1) WO2011077286A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012085711A1 (fr) * 2010-12-23 2012-06-28 Kimberly-Clark Worldwide, Inc. Dispositif de cathéter d'alimentation entérale comportant un indicateur
GB2494749A (en) * 2012-07-12 2013-03-20 Iden Shams Enteral feeding device comprising a button and connector
AU2011346709B2 (en) * 2010-12-10 2015-12-24 Avent, Inc. Infusion apparatus with flow indicator
AU2015268574B2 (en) * 2010-12-10 2017-01-19 Avent, Inc. Infusion apparatus with flow indicator

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006004943A2 (fr) 2004-06-29 2006-01-12 C. R. Bard, Inc. Procedes et systemes assurant une communication par voie fluide avec un tube de gastrostomie
EP2451512A1 (fr) 2009-07-07 2012-05-16 C.R. Bard Inc. Traverse interne extensible pour un dispositif médical
WO2011100310A2 (fr) * 2010-02-09 2011-08-18 C.R. Bard, Inc. Indicateur de dégonflage pour coussin de dispositif médical
US8177742B1 (en) 2010-12-23 2012-05-15 Kimberly-Clark Wordwide, Inc. Inflatable retention system for an enteral feeding device
CN102357274B (zh) * 2011-09-23 2013-02-06 苏勇 带有防止胃内容物返流装置的胃管
US9033930B2 (en) 2011-12-22 2015-05-19 Avent, Inc. Base for an enteral feeding device
US9700489B2 (en) * 2012-07-13 2017-07-11 Avent, Inc. Feeding tube tip reinforcement
US9364358B2 (en) 2012-07-27 2016-06-14 Medinol Ltd. Catheter with retractable cover and pressurized fluid
US9572960B2 (en) 2012-10-01 2017-02-21 C.R. Bard, Inc. Balloon catheter having multiple inflation lumens and related methods
DE102014201258A1 (de) * 2014-01-23 2015-07-23 B. Braun Melsungen Ag Verfahren und Vorrichtung zur Kontrolle des Durchflusses durch eine medizinische Infusionsleitung
US9925359B2 (en) 2014-03-21 2018-03-27 Medtronic Cryocath Lp Balloon design to reduce distal length
US10350396B2 (en) * 2014-06-27 2019-07-16 Acclarent, Inc. Vent cap for a Eustachian tube dilation system
CA3003289C (fr) * 2015-10-29 2024-05-07 Convatec Technologies Inc. Systeme de soupape pour dispositifs gonflables
JP2019511338A (ja) 2016-04-12 2019-04-25 セイフ・メディカル・デザイン・インコーポレイテッド 安全な導尿カテーテル及びその製造方法
US20180207369A1 (en) * 2017-01-23 2018-07-26 Enable Injections, Inc. Medical fluid injection device with fill indicator
WO2018150217A1 (fr) 2017-02-16 2018-08-23 N.V. Nutricia Dispositif de gastrostomie avec surveillance de pression
US11247011B2 (en) * 2017-12-26 2022-02-15 Xialing Zhang Pressure controller and tracheal breathing tube comprising same
US10974031B2 (en) * 2017-12-28 2021-04-13 Biosense Webster (Israel) Ltd. Balloon catheter with internal distal end
CN111839618B (zh) * 2019-04-30 2024-02-27 上海科赐医疗技术有限公司 具有自然腔道显示装置的医用非对称球囊导管
GB201907070D0 (en) 2019-05-20 2019-07-03 Metis Design Bv Connector for a gastrostomy device
WO2023036681A1 (fr) 2021-09-07 2023-03-16 Fresenius Kabi Deutschland Gmbh Cathéter à ballonnet pour alimentation entérale

Citations (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3642005A (en) 1970-02-11 1972-02-15 Gerald E Mcginnis Endotracheal tube with inflatable cuff
US3780693A (en) 1972-05-15 1973-12-25 E Parr Visible fluid pressure indicator
US3915171A (en) 1974-06-06 1975-10-28 Dennis William Shermeta Gastrostomy tube
US4111407A (en) 1976-09-30 1978-09-05 Litton Industrial Products, Inc. Conical compression spring
US4266550A (en) 1977-01-10 1981-05-12 Bruner James D Pressure indicators for inflatable cuff-type catheters
US4315513A (en) 1980-03-10 1982-02-16 Nawash Michael S Gastrostomy and other percutaneous transport tubes
US4944732A (en) 1988-08-15 1990-07-31 Sandoz Nutrition Corporation Gastrostomy feeding port
US5218970A (en) 1990-12-05 1993-06-15 Smiths Industries Public Limited Company Tracheal tube cuff pressure monitor
US5484420A (en) 1992-07-09 1996-01-16 Wilson-Cook Medical Inc. Retention bolsters for percutaneous catheters
US20030225376A1 (en) * 2002-05-28 2003-12-04 Sherwood Services, Ag External inflation indicator for a low profile gastrostomy tube
US6732734B2 (en) 2001-04-27 2004-05-11 Kuraray Co., Ltd. Pilot balloon for balloon catheters
US7018359B2 (en) 1999-06-25 2006-03-28 Koken Co., Ltd. Inner pressure indicator of cuff
WO2007103681A2 (fr) * 2006-03-08 2007-09-13 Kyphon Sarl Appareil fournissant une indication qualitative associée au gonflement d'un élément dilatable
US7383736B2 (en) 2002-05-24 2008-06-10 Ultimate Medical Pty Ltd Device and method for pressure indication
US7404329B2 (en) 2004-12-08 2008-07-29 Engineered Medical Systems, Inc. Pressure gauge for use with an airway lumen
EP2060293A1 (fr) * 2007-11-14 2009-05-20 Advanex Inc. Indicateur pour dispositif médical à ballonnet
WO2009135141A1 (fr) * 2008-05-01 2009-11-05 Bristol-Myers Squibb Company Appareil de drainage rectal

Family Cites Families (63)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3409016A (en) * 1964-04-08 1968-11-05 Selflate Corp Disposable cartridge for inflating bag catheters
US3630198A (en) * 1969-06-23 1971-12-28 Henkin Melvyn Lane Catheter placement device
US3731691A (en) * 1970-09-24 1973-05-08 Lorton Labor Ltd Endotracheal tube and connector unit
US3980082A (en) * 1975-03-14 1976-09-14 William Miller Venous pressure indicator
US4134407A (en) * 1977-03-25 1979-01-16 Elam James O External pressure-volume monitor for endotracheal cuff
US4159722A (en) * 1977-03-28 1979-07-03 Sherwood Medical Industries, Inc. Pressure regulator for endotracheal tube cuff or the like
US4178939A (en) * 1977-09-29 1979-12-18 Portex, Inc. Visual indicator for cuff-type catheter
US4236880A (en) 1979-03-09 1980-12-02 Archibald Development Labs, Inc. Nonpulsating IV pump and disposable pump chamber
US4245639A (en) * 1979-04-30 1981-01-20 C. R. Bard, Inc. Self-inflating urinary catheter
US4277227A (en) * 1979-07-02 1981-07-07 Imed Corporation Apparatus for converting a pump to a controller
US4272368A (en) * 1979-09-04 1981-06-09 Parker-Hannifin Corporation Fluid filter and indicator
US4502490A (en) * 1980-10-28 1985-03-05 Antec Systems Limited Patient monitoring equipment, probe for use therewith, and method of measuring anesthesia based on oesophagal contractions
US4361107A (en) * 1980-11-20 1982-11-30 Gereg Gordon A Overinflation indicator for tracheal tubes
US4384584A (en) * 1981-10-28 1983-05-24 Chen Allen S Method and means for esophageal feeding
US4522194A (en) * 1983-02-18 1985-06-11 Baylor College Of Medicine Method and an apparatus for intra-aortic balloon monitoring and leak detection
US4598707A (en) * 1984-06-21 1986-07-08 Sherwood Medical Company Medical tube with inflation cuff
GB2176595A (en) 1985-06-05 1986-12-31 Warner Lambert Co Pressure sensing device
US4793351A (en) * 1987-06-15 1988-12-27 Mansfield Scientific, Inc. Multi-lumen balloon catheter
DE3816128C1 (fr) * 1988-05-11 1989-09-28 Mc Medizingeraete Gmbh, 8755 Alzenau, De
EP0490979B1 (fr) * 1989-09-08 1996-11-13 Boston Scientific Corporation Angioplastie a faible contrainte physiologique
US5103817A (en) * 1990-07-20 1992-04-14 Xomed-Treace Inc. Automatic dye dispersant for endotracheal tubes and catheters
US5201755A (en) * 1990-09-11 1993-04-13 Datascope Investment Corp. Method and apparatus for early detection of leakage and failure of a balloon membrane of a balloon catheter
DE4237978C1 (de) 1992-11-11 1994-02-24 Braun Melsungen Ag Druckanzeiger als Einmalartikel für medizinische Geräte
ZA954936B (en) * 1994-06-17 1996-02-27 Trudell Medical Ltd Nebulizing catheter system and methods of use and manufacture
DE69621462T2 (de) 1996-02-26 2002-11-14 T. Smedegaard A/S, Glostrup Gerät zur verwendung in einem flüssigkeitskreislauf und verfahren zur verwendung eines solchen geräts
US6082361A (en) * 1997-09-12 2000-07-04 Morejon; Orlando Endotracheal tube cleaning apparatus
US6004305A (en) * 1996-05-03 1999-12-21 Spectrum Medsystems, Inc. Drainage catheter assembly
US5792070A (en) * 1996-08-30 1998-08-11 Urologix, Inc. Rectal thermosensing unit
US5997503A (en) * 1998-02-12 1999-12-07 Ballard Medical Products Catheter with distally distending balloon
US5992239A (en) * 1998-09-10 1999-11-30 Boehringer Laboratories, Inc. Gauge
GB9825881D0 (en) * 1998-11-27 1999-01-20 Smiths Industries Plc Inflation indicators
US6536260B2 (en) * 1999-06-24 2003-03-25 Datascope Investment Corp. Balloon catheter leak detection method and apparatus
ES2205956B1 (es) * 2000-10-16 2005-04-01 Probitas Pharma S.A. Aparato para inflado y desinflado de cateteres con balon y procedimiento de utilizacion del mismo.
GB2371754B (en) * 2001-02-02 2005-09-21 Biocompatibles Ltd Balloon catheter inflation
US6800069B2 (en) * 2002-05-06 2004-10-05 Merit Medical Systems, Inc. Modularized infusion pump apparatus
US7025718B2 (en) * 2002-11-19 2006-04-11 Jonathan Williams Method and device for correcting in-vivo sensor drift
US20040106901A1 (en) * 2002-11-30 2004-06-03 Letson William W. Catheter having a balloon member invertedly attached thereto
US20040106899A1 (en) * 2002-11-30 2004-06-03 Mcmichael Donald J. Gastric balloon catheter with improved balloon orientation
US7331979B2 (en) * 2003-06-04 2008-02-19 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US20040267195A1 (en) * 2003-06-24 2004-12-30 Arnoldo Currlin Catheter balloon having visible marker
US7468051B2 (en) * 2004-03-02 2008-12-23 Boston Scientific Scimed, Inc. Occlusion balloon catheter with external inflation lumen
US7112186B2 (en) * 2004-05-26 2006-09-26 Shah Tilak M Gastro-occlusive device
JP3859081B2 (ja) * 2004-11-04 2006-12-20 フジノン株式会社 内視鏡装置用のバルーン制御装置
US8382708B2 (en) * 2005-01-26 2013-02-26 Mayser, Llc Zero-pressure balloon catheter and method for using the catheter
US20080228138A1 (en) * 2005-03-31 2008-09-18 Van Sloten Leonard A Catheter with balloon having visual marker
US7195612B2 (en) * 2005-03-31 2007-03-27 Gordis Corporation Esophageal balloon catheter with visual marker
JP5038294B2 (ja) 2005-04-22 2012-10-03 アクセスクロージャー，インク． 組織の穿刺を塞ぐ装置および方法
US9345604B2 (en) * 2005-05-02 2016-05-24 Almuhannad Alfrhan Percutaneous intragastric balloon device and method
US8951225B2 (en) * 2005-06-10 2015-02-10 Acclarent, Inc. Catheters with non-removable guide members useable for treatment of sinusitis
DE102005028428A1 (de) * 2005-06-17 2006-12-28 Microcuff Gmbh Vorrichtung zur gastrischen Ernäherung und Drainage über eine transkutan angelegte Fistel
US8221348B2 (en) * 2005-07-07 2012-07-17 St. Jude Medical, Cardiology Division, Inc. Embolic protection device and methods of use
WO2007017880A2 (fr) * 2005-08-11 2007-02-15 Stimplant Ltd. Dispositif implantable pour la prevention de l'obesite
US7744559B2 (en) * 2006-12-19 2010-06-29 Cytyc Corporation Systems and methods for drug infusion with feedback control
WO2008134355A2 (fr) * 2007-04-24 2008-11-06 Vidacare Corporation Poche intraosseuse haute pression, et procédé
EP2157996B1 (fr) * 2007-05-21 2019-07-24 Smart Medical Systems Ltd. Cathéter comprenant une partie pouvant être courbée
EP2160133B1 (fr) * 2007-06-27 2020-08-19 Flip Technologies Limited Système mis en place dans un processus d'amélioration de la fonction d'obturation du sphincter
DE102007053980A1 (de) 2007-11-13 2009-05-14 Pfeiffer Vacuum Gmbh Vakuumpumpe
WO2009081387A1 (fr) * 2007-12-20 2009-07-02 Flip Technologies Limited Procédé et appareil de détermination du volume d'un récipient
US20100081991A1 (en) * 2008-09-30 2010-04-01 Tyco Healthcare Group Lp Skin level device for use with gastrostomy tube
GB2480166B (en) 2008-12-20 2013-07-24 Jude Paul Pullen Improved medical tube
JP5280830B2 (ja) 2008-12-24 2013-09-04 クリエートメディック株式会社 カフ内圧モニター装置
US8523818B2 (en) * 2009-01-19 2013-09-03 Kimberly-Clark Worldwide, Inc. Enteral feeding assembly with obturator
US9259564B2 (en) * 2009-01-22 2016-02-16 Avent, Inc. Enteral feeding assembly with lock assembly

Patent Citations (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3642005A (en) 1970-02-11 1972-02-15 Gerald E Mcginnis Endotracheal tube with inflatable cuff
US3780693A (en) 1972-05-15 1973-12-25 E Parr Visible fluid pressure indicator
US3915171A (en) 1974-06-06 1975-10-28 Dennis William Shermeta Gastrostomy tube
US4111407A (en) 1976-09-30 1978-09-05 Litton Industrial Products, Inc. Conical compression spring
US4266550A (en) 1977-01-10 1981-05-12 Bruner James D Pressure indicators for inflatable cuff-type catheters
US4315513A (en) 1980-03-10 1982-02-16 Nawash Michael S Gastrostomy and other percutaneous transport tubes
US4944732A (en) 1988-08-15 1990-07-31 Sandoz Nutrition Corporation Gastrostomy feeding port
US5218970A (en) 1990-12-05 1993-06-15 Smiths Industries Public Limited Company Tracheal tube cuff pressure monitor
US5484420A (en) 1992-07-09 1996-01-16 Wilson-Cook Medical Inc. Retention bolsters for percutaneous catheters
US7018359B2 (en) 1999-06-25 2006-03-28 Koken Co., Ltd. Inner pressure indicator of cuff
US6732734B2 (en) 2001-04-27 2004-05-11 Kuraray Co., Ltd. Pilot balloon for balloon catheters
US7383736B2 (en) 2002-05-24 2008-06-10 Ultimate Medical Pty Ltd Device and method for pressure indication
US20030225376A1 (en) * 2002-05-28 2003-12-04 Sherwood Services, Ag External inflation indicator for a low profile gastrostomy tube
US6878130B2 (en) 2002-05-28 2005-04-12 Sherwood Services Ag External inflation indicator for a low profile gastrostomy tube
US7404329B2 (en) 2004-12-08 2008-07-29 Engineered Medical Systems, Inc. Pressure gauge for use with an airway lumen
WO2007103681A2 (fr) * 2006-03-08 2007-09-13 Kyphon Sarl Appareil fournissant une indication qualitative associée au gonflement d'un élément dilatable
EP2060293A1 (fr) * 2007-11-14 2009-05-20 Advanex Inc. Indicateur pour dispositif médical à ballonnet
WO2009135141A1 (fr) * 2008-05-01 2009-11-05 Bristol-Myers Squibb Company Appareil de drainage rectal

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2011346709B2 (en) * 2010-12-10 2015-12-24 Avent, Inc. Infusion apparatus with flow indicator
AU2015268574B2 (en) * 2010-12-10 2017-01-19 Avent, Inc. Infusion apparatus with flow indicator
WO2012085711A1 (fr) * 2010-12-23 2012-06-28 Kimberly-Clark Worldwide, Inc. Dispositif de cathéter d'alimentation entérale comportant un indicateur
US8672882B2 (en) 2010-12-23 2014-03-18 Kimbery-Clark Worldwide, Inc. Enteral feeding catheter device with an indicator
GB2494749A (en) * 2012-07-12 2013-03-20 Iden Shams Enteral feeding device comprising a button and connector
GB2494749B (en) * 2012-07-12 2013-09-18 Iden Shams Enteral feeding devices, buttons and/or connectors
US9066850B2 (en) 2012-07-12 2015-06-30 Iden Shams Enteral feeding devices, buttons, and/or connectors

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JP5809639B2 (ja) 2015-11-11
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KR101743015B1 (ko) 2017-06-15
EP2515825A1 (fr) 2012-10-31
MX338783B (es) 2016-05-02
US10085922B2 (en) 2018-10-02
ES2589779T3 (es) 2016-11-16
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CN102665646B (zh) 2016-08-31
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AU2010334500A1 (en) 2012-06-14
EP2591764B1 (fr) 2017-03-22
CA2781494A1 (fr) 2011-06-30
RU2012131060A (ru) 2014-03-20
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US20160000658A1 (en) 2016-01-07
US9132064B2 (en) 2015-09-15
EP2591764A1 (fr) 2013-05-15
CA2781494C (fr) 2018-01-09

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